Study on 30 Outpatients With Chronic Migraine Treated With Well-Being Therapy or With a Control Therapy

Chronic Migraine Clinical Trial

Official title:

Pilot Randomized Controlled Trial to Evaluate the Efficacy of Well-Being Therapy vs a Control Condition in Chronic Migraine Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03404336
• Other study ID #: WBT in MIG
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2018
• Est. completion date: December 30, 2024

Study information

• Verified date: May 2023
• Source: University of Florence
• Contact: Fiammetta COSCI, Prof.
• Phone: 0552755066
• Email: fiammetta.cosci[@]unifi.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Chronic migraine is a disabling type of migraine and is often resistant to treatment. Non-pharmacological interventions have been investigated as potential treatment although, unfortunately, the literature on their efficacy is poor and showed mixed results. Well-Being Therapy (WBT) is a brief psychotherapy which has shown efficacy in decreasing the relapse rates of depression in adults, in generalized anxiety disorder and in cyclothymia. It can be implemented to empower psychological well-being. The aim of the present study is to test the efficacy of WBT in a sample of patients with chronic migraine to verify if it reduces the disability due to migraine and distress, it increases the psychological well-being as well as the level of euthymia.

Description:

Chronic migraine is a disabling type of migraine and is often resistant to treatment. Non-pharmacological interventions have been investigated as potential treatment although, unfortunately, the literature on their efficacy is poor and showed mixed results. The psychological interventions tested up to now are the Acceptance and Commitment Therapy and the Mindfulness. Well-Being Therapy (WBT) is a brief psychotherapy which has been manualized in 2016 and has shown efficacy in randomized clinical trials. It showed to be effective in decreasing the relapse rates of depression in adults, it showed to be effective in generalized anxiety disorder and in cyclothymia. Thus, psychological well-being can be implemented and empowered via a specific psychotherapy and this implementation might produce a protecting effect, thus favoring prevention. The aim of the present study is to test the efficacy of WBT in a sample of patients with chronic migraine. First the efficacy of WBT will be verified in terms of disability due to migraine. Then, the efficacy of WBT will be measured in terms of psychological well-being, euthymia, and distress. For this purpose, 30 chromic migraine outpatients will be enrolled in a randomized, controlled, open clinical study.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 30, 2024
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion criteria:

1. able and interested in participating to the present research project, as proved by signed Informed consent;

2. 18-65 years of age;

3. Italian mother tongue;

4. diagnosis of chronic migraine according to the International Classification of Headache Disorders. Thus, presenting specific features (i.e., unilateral and pulsating pain of moderate or severe intensity, which is aggravated or precipitated by routine physical activities and is combined with nausea and/or vomiting, photophobia, and phonophobia) and migraine headache on = 15 days per month;

5. headache chronicity for a minimum of 1 year and pattern of headache symptoms stable for a period of at least 6 months;

6. no pharmacological therapy or dietary supplements use for chronic migraine OR pharmacological therapy/dietary supplement use for chronic migraine stable since at least 3 months;

7. psychotropic medication allowed only if stable since at least three months.

Exclusion criteria:

1. diagnosis of medication overuse headache;

2. co-occurrence of psychiatric disorder(s) according to the Diagnostic and Statistical Manual of mental disorders (DSM) 5th edition as diagnosed via the MINI International Neuropsychiatric Interview;

3. co-occurrence of chronic unstable medical conditions;

4. being pregnant or lactating;

5. under exogeneous hormones treatment (i.e., hormonal contraceptives, postmenopausal hormone therapy);

6. any other condition that, according to the Investigators' opinion, may alter the ability of the patient to follow study procedures.

Related Conditions & MeSH terms

• Chronic Migraine
• Migraine Disorders

Intervention

Behavioral:
• Well-Being Therapy
Session 1: identifying and setting episodes of wellbeing into situational context. Session 2: identifying interfering thoughts and behaviors. Session 3: illustrating autonomy, reflecting and practicing it. Session 4: illustrating environmental mastery, reflecting and practicing it. Session 5: illustrating positive relations with others, reflecting and practicing it. Session 6: illustrating personal growth, reflecting and practicing it. Session 7: illustrating self-acceptance, reflecting and practicing it. Session 8: illustrating purpose in life, reflecting and practicing it.

Other:
• Control condition
Session 1: illustrating the concept of lifestyle and well-being. Session 2 and session 3: illustrating healthy eating and steps to healthy eating. Session 4: illustrating physical exercise and how it promotes health. Session 5: illustrating smoking and tobacco and how they can damage health. Session 6: illustrating alcohol and how it can damage health. Session 7: illustrating drugs misuse and how it can damage health. Session 8: illustrating sexual health. No access to specific WBT ingredients will be allowed.

Locations

Country	Name	City	State
Italy	Centro Cefalee e Farmacologia Clinica	Florence
Italy	Fiammetta COSCI	Florence

Sponsors (1)

Lead Sponsor	Collaborator
University of Florence

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	disability due to migraine	level of disability due to migraine assessed via the Migraine Disability Assessment Score (score from 0 to >21, for total score > 6 disability is clinically relevant)	from baseline to 3-month follow up
Primary	frequency of migraine attacks	frequency of migraine attacks assessed via a daily self-report headache diary (higher the frequency, higher the severity of migraine)	from baseline to 3-month follow up
Primary	duration of migraine attacks	duration of migraine attacks assessed via a daily self-report headache diary (higher the duration, higher the severity of migraine)	from baseline to 3-month follow up
Primary	intensity of migraine attacks	intensity of migraine attacks assessed via a daily self-report headache diary (higher the intensity, higher the severity of migraine)	from baseline to 3-month follow up
Secondary	level of anxiety and depression	the level of anxiety and depression will be assessed via the Symptom Questionnaire (total score from 0 to 92, higher is the total score and worse is the symptomatology)	from baseline to 3-month follow up
Secondary	level of psychological well-being	assessed via the World Health Organization-Five Well-Being Index (WHO 5) (total score from 0 to 25, higher total score means higher quality of life)	from baseline to 3-month follow up
Secondary	level of psychological well-being	assessed via Psychological Well-Being Questionnaire (PWB) (total score from 84 to 504, higher score corresponds to higher psychological well-being)	from baseline to 3-month follow up
Secondary	the level of euthymia	the level of euthymia will be assessed via the euthymia scale (total score from 0 to 10, higher score corresponds to higher level of euthymia)	from baseline to 3-month follow up